Parents in the Tylenol autism lawsuit allege that taking acetaminophen during pregnancy caused autism spectrum disorder or ADHD in their children. The cases name the maker of Tylenol and retailers of store-brand acetaminophen.
The federal cases are coordinated in New York under MDL No. 3043, with Judge Denise Cote presiding. On July 13, 2026, the Second Circuit vacated the exclusion of three plaintiffs' experts and sent the cases back to the district court.
Kenvue, which makes Tylenol, and several retailers have asked the Second Circuit to revisit that ruling. No court has found that acetaminophen causes autism or ADHD, and no settlement has been announced.
- Case or litigation name: In re Acetaminophen – ASD-ADHD Products Liability Litigation (MDL No. 3043)
- Defendants: Johnson & Johnson Consumer Inc. (JJCI), named as Tylenol’s maker in court opinions; Kenvue Brands LLC, which makes Tylenol; store-brand acetaminophen retailers
- Court and docket number, when available: U.S. District Court, Southern District of New York, MDL docket 1:22-md-3043 (DLC); Second Circuit appeal No. 24-916
- MDL number, judge, and case count, when an MDL exists: MDL No. 3043, Judge Denise Cote; approximately 550 cases (judgments vacated July 13, 2026)
- Filing date: October 5, 2022 (Judicial Panel on Multidistrict Litigation transfer order)
- Main allegations: Plaintiffs allege that the defendants failed to warn that prenatal acetaminophen exposure can cause autism spectrum disorder (ASD) or ADHD
- Products or people involved: Tylenol and store-brand acetaminophen taken during pregnancy; children later diagnosed with ASD, ADHD or both
Latest Tylenol Autism Lawsuit Updates
September 11, 2026: Law360 Reports Kenvue and Retailers Asked the Second Circuit to Revisit Its Ruling
Law360 Healthcare Authority reported that Kenvue and several retailers asked the Second Circuit to revisit its decision [1]. Kenvue makes Tylenol.
That decision overturned the district court's exclusion of expert testimony offered by plaintiffs. The request followed the ruling of July 13, 2026.
July 13, 2026: Second Circuit Revives the Tylenol Autism Cases
The Second Circuit said a lower court had wrongly excluded plaintiffs' experts, Law360 reported [2]. The experts would testify about an alleged link between Tylenol use in pregnancy and autism or ADHD.
Kenvue said the court reversed the exclusion of three experts, upheld two exclusions and vacated the judgments [3]. The cases go back to the Southern District of New York.
October 28, 2025: Texas Attorney General Sues Johnson & Johnson and Kenvue
The Texas Attorney General announced a lawsuit against Johnson & Johnson and Kenvue. It alleges they deceptively marketed Tylenol to pregnant women, violating Texas consumer protection laws [4].
The release also alleges that Johnson & Johnson fraudulently transferred Tylenol liabilities to Kenvue. It says that violated the Texas Uniform Fraudulent Transfer Act. These are the State's allegations.
September 24, 2025: WHO Says No Consistent Association Has Been Established
The World Health Organization stated that there is currently no conclusive scientific evidence confirming a possible link between autism and acetaminophen use during pregnancy [5].
It said extensive research has been done, including large-scale studies. No consistent association has been established at this time. WHO recommends that all women continue to follow the advice of their doctors or health workers.
September 22, 2025: FDA Starts an Acetaminophen Label Change
The FDA announced that it had started the process for a label change for acetaminophen [6]. It also sent a letter to physicians.
Both concern evidence suggesting a possible association with autism and ADHD. The FDA also said a causal relationship has not been established. It said contrary studies exist in the scientific literature.
July 10, 2024: Judge Cote Excludes Dr. Ness's ADHD Opinion
Judge Denise Cote ruled that the ADHD causation opinion of Dr. Roberta Ness was unreliable and inadmissible [7]. Plaintiffs in newly filed actions offered Dr. Ness. The ruling followed the December 2023 decision on five other experts.
April 9, 2024: Swedish Sibling Study Finds No Differences
Karolinska Institutet and Drexel University researchers published a JAMA study of 2.4 million children born in Sweden between 1995 and 2019 [8]. It looked at autism, ADHD and intellectual disability.
Across the whole population, the authors saw a slight increase in those conditions. Siblings exposed and unexposed to paracetamol in the womb were then compared. The researchers found no differences.
December 18, 2023: Judge Cote Excludes Five Plaintiffs' Experts
Judge Denise Cote excluded the testimony of five experts [9]. The plaintiffs offered them to say prenatal acetaminophen exposure causes autism and ADHD.
The ruling followed oral argument on December 7, 2023. That hearing covered the defendants' motions to strike the plaintiffs' expert reports.
October 5, 2022: Panel Centralizes the Cases as MDL No. 3043
The Judicial Panel on Multidistrict Litigation centralized the acetaminophen autism and ADHD cases in New York as MDL No. 3043 [10]. Judge Denise Cote was named to hear them.
The litigation then consisted of 18 actions pending in seven districts. The Panel had also been notified of 47 related actions.
What Is Acetaminophen?
According to MedlinePlus, acetaminophen is used to relieve mild to moderate pain and to reduce fever [11]. The court's July 2024 opinion calls it the active ingredient in Tylenol and certain other over-the-counter pain relievers.
MedlinePlus adds that no evidence to date has been able to show that acetaminophen in pregnancy causes autism or ADHD, although some studies have shown an association.
Who May Be Affected?
Mothers who took over-the-counter acetaminophen during pregnancy may be affected. The product can be Tylenol or a store-brand generic. The cases involve children later diagnosed with autism, ADHD or both.
Retailers of store-brand products are defendants too. Whether a family qualifies depends on an individual legal review of its own facts.
Reported Injuries or Damages
Plaintiffs allege that prenatal acetaminophen exposure caused their children's autism spectrum disorder, ADHD or both. The Panel's October 2022 order says plaintiffs commonly allege that both are neurodevelopmental disorders caused by acetaminophen's effect on brain development before birth.
The plaintiffs assert state-law claims. These include strict liability for failure to warn and for design defect. They also include negligence, negligent misrepresentation by omission and breach of implied warranty. The court's December 2023 opinion lists them.
Kenvue says credible, independent science shows no proven link between taking acetaminophen and autism or ADHD. It says it will continue to defend the cases.
The FDA cited cohort studies, including the Nurses' Health Study II and the Boston Birth Cohort, that find an association with autism and ADHD. It said the risk may be most pronounced with chronic use throughout pregnancy.
The National Institute of Child Health and Human Development says autism probably has many causes. It says genes are one of the main causes or a major contributor [12].
Recall and Regulatory Background
No recall of Tylenol or acetaminophen has been announced over the autism and ADHD claims. The FDA said in September 2025 that it remains reasonable for pregnant women to use acetaminophen in certain scenarios.
Evidence to Preserve
Records that show how and when acetaminophen was used can matter in a claim. Keep these items:
- Purchase records and packaging for each acetaminophen product used, such as receipts, pharmacy or store records, and photographs of the box or bottle
- Prenatal and pharmacy records that show when and how often acetaminophen was taken
- Your child's diagnosis and treatment records for autism spectrum disorder or ADHD
- Family medical history for the mother, the child and close relatives
- Notes and messages about the pregnancy and any medication advice from doctors
Filing Deadlines
Filing deadlines come from state law. They vary with where you live and with when the exposure and your child's diagnosis happened.
If Washington law applies, its product liability statute allows no claim more than three years after the claimant discovered, or should have discovered, the harm and its cause, with tolling and extension exceptions in chapter 4.16 RCW [13].
Under RCW 4.16.190, time under age eighteen is not counted toward the limit for starting an action [14]. Missing a deadline can end a claim even when the facts are strong, so ask a lawyer promptly.
Frequently Asked Questions
Is the Tylenol Autism Lawsuit Still Active?
Yes, the Tylenol autism lawsuit is still active. The Second Circuit remanded the cases to the District Court for further review. Timing for that review is set by the District Court and any further appellate review.
How Much Is the Tylenol Autism Lawsuit Settlement Worth?
There is no Tylenol autism lawsuit settlement amount because no settlement, verdict or global resolution has been announced. Kenvue said it stands behind the safety of its product and will continue to defend the cases.
Does the Tylenol Autism Lawsuit Cover Generic Acetaminophen?
The Tylenol autism lawsuit covers generic acetaminophen as well as Tylenol. The cases allege use of over-the-counter generic products during pregnancy. The Judicial Panel on Multidistrict Litigation noted that defendants sell different store brands, but the active ingredient is the same in all actions.
What Does the Research Say About Acetaminophen in Pregnancy and Autism?
Research on acetaminophen in pregnancy and autism includes a Swedish JAMA study that compared siblings and found no differences. A 2021 consensus statement in Nature Reviews Endocrinology urged caution, and 60 scientists and clinicians disagreed in a counterstatement, according to the court's July 2024 opinion.
Has Any Court Found That Tylenol Causes Autism?
The Second Circuit has not found that Tylenol causes autism. Kenvue's statement quotes the court as saying it was not deciding whether there is a general causal relationship between acetaminophen and ADHD or ASD.
References
- https://www.mlex.com/healthcare-authority/other/articles/2524556/tylenol-maker-seeks-2nd-circ-relook-in-autism-adhd-suits
- https://www.law360.com/healthcare-authority/articles/2500308
- https://www.kenvue.com/media/second-circuit-court-of-appeals-ruling
- https://texasattorneygeneral.gov/news/releases/attorney-general-paxton-sues-big-pharma-manufacturers-deceptively-marketing-tylenol-pregnant-mothers
- https://www.who.int/news/item/24-09-2025-who-statement-on-autism-related-issues
- https://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy
- https://www.nysd.uscourts.gov/sites/default/files/pdf/MDL/22mc3043/22md3043%202nd%20Daubert%20Opinion.pdf
- https://news.ki.se/no-link-between-paracetamol-use-during-pregnancy-and-autism-or-adhd-in-children
- https://www.nysd.uscourts.gov/sites/default/files/pdf/MDL/22mc3043/2023.12.28%20%20-%20In%20re%20Acetaminophen%20(Daubert).pdf
- https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3043-Initial-Transfer-Order-9-22.pdf
- https://medlineplus.gov/druginfo/meds/a681004.html
- https://www.nichd.nih.gov/health/topics/autism/conditioninfo/causes
- https://app.leg.wa.gov/RCW/default.aspx?cite=7.72.060
- https://app.leg.wa.gov/RCW/default.aspx?cite=4.16.190